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Binosto

Binosto

alendronic acid

Manufacturer:

SwissCo Services

Distributor:

Multicare
Concise Prescribing Info
Contents
Alendronic acid
Indications/Uses
Postmenopausal osteoporosis. Reduces risk of vertebral & hip fractures.
Dosage/Direction for Use
70 mg effervescent tab once wkly.
Administration
Should be taken on an empty stomach: Take at least 30 min before 1st food, beverage, or medicinal product of the day w/ plain water only. Do not lie down for at least 30 min after drinking the oral soln. Do not swallow the undissolved effervescent tab. Do not chew or allow the effervescent tab to dissolve in the mouth.
Contraindications
Hypersensitivity. Abnormalities of oesophagus & other factors which delay oesophageal emptying eg, stricture or achalasia. Inability to stand or sit upright for at least 30 min. Hypocalcaemia.
Special Precautions
Causes local irritation of the upper GI mucosa. Caution in patients w/ active upper GI problems eg, dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or w/ recent history (1 yr) of major GI diseases eg, peptic ulcer, or active GI bleeding, or upper GIT surgery other than pyloroplasty. Risk of oesophageal reactions; greater risk & severity in patients who fail to take alendronate properly &/or who continue to take alendronate after developing symptoms suggestive of oesophageal irritation. Reports of osteonecrosis of the jaw. Avoid invasive dental procedures if possible while on treatment. Encourage patients to maintain good oral hygiene, receive routine dental check-ups, & report any oral symptoms eg, dental mobility, pain or swelling. Reports of bone, joint, &/or muscle pain; atypical subtrochanteric & diaphyseal femoral fractures, primarily in patients receiving long-term treatment for osteoporosis; severe skin reactions including SJS & TEN (rare); osteonecrosis of the external auditory canal, mainly in association w/ long-term therapy. Hypocalcaemia must be corrected before initiating therapy. Other disorders affecting mineral metabolism (eg, vit D deficiency & hypoparathyroidism) should be effectively treated before starting treatment; monitor serum Ca & symptoms of hypocalcaemia during therapy in patients w/ these conditions. Decreases in serum Ca & phosphate may occur especially in patients taking glucocorticoids. Ensure adequate Ca & vit D intake, particularly in patients receiving glucocorticoids. Contains 26.2 mmol (602.54 mg) Na/dose; consider Na content in patients on controlled Na diet. Certain reported adverse reactions may affect some patients' ability to drive or operate machinery. Not recommended in patients w/ renal impairment where GFR is <35 mL/min. Not to be used during pregnancy. Should not be used by breast-feeding women. Not recommended for use in childn <18 yr.
Adverse Reactions
Musculoskeletal (bone, muscle or joint) pain. Headache, dizziness; vertigo; abdominal pain/distension, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, acid regurgitation; alopecia, pruritus; joint swelling; asthenia, peripheral oedema.
Drug Interactions
Interfered absorption w/ food & beverages (including mineral water), Ca supplements, antacids & some oral drugs. Increased risk of GI irritation w/ NSAIDs.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Form
Binosto effervescent tab 70 mg
Packing/Price
12's;4's
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